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Drug

Belimumab

Established medicine
ClassTumor necrosis factor ligand superfamily member 13B inhibitorResearchActive indication expansion

Also known as Benlysta.

RxNorm1092437ChEMBLCHEMBL1789843ATCL04AG04UNII73B0K5S26A
14
Active clinical trials
TNFSF13B
Primary target
32
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Belimumab Administered Subcutaneously in Adults With Interstitial Lung Disease (ILD) Associated With Connective Tissue Disease (CTD)

Clinical trial2026-09-08Results expected Q3 2029 · ClinicalTrials.gov

A Phase 1 Evaluation of the Safety of Belimumab in People With Idiopathic CD4 Lymphopenia and Autoantibodies (Phoebe)

Clinical trial2026-08-27Results expected Q1 2027 · ClinicalTrials.gov

Label change: BELIMUMAB (BLA125370)

Regulatory2026-08-21FDA

Label change: BELIMUMAB (BLA761043)

Regulatory2026-08-21FDA

A Randomized Controlled Phase I Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GNC-038 Tetra-specific Antibody Injection in Systemic Lupus Erythematosus

Clinical trial2026-07-10Results expected Q4 2027 · ClinicalTrials.gov

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Clinical trial2026-07-09Results expected Q1 2028 · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled Study of Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy (ITN080AI)

Clinical trial2026-06-24Results expected Q1 2029 · ClinicalTrials.gov

A Phase 1, First-time-in-human, Four-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GSK4527363 in Healthy Participants (Part A), Participants With Active Systemic Lupus Erythematosus (Part B), Healthy Participants of Chinese and Japanese Descent (Part C) and Participants With Interstitial Lung Disease Associated With Connective Tissue Disease (Part D)

Clinical trial2026-06-22Results expected Q1 2028 · ClinicalTrials.gov

Pilot Trial of Belimumab in Early Lupus

Clinical trial2026-06-12Results expected Q3 2028 · ClinicalTrials.gov

Indication expansion: BELIMUMAB (BLA761043)

Regulatory2025-06-20FDA

Label change: BELIMUMAB (BLA125370)

Regulatory2025-06-20FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Belimumab
Aliases & brands
Benlysta
RxNorm CUI
1092437
ChEMBL ID
CHEMBL1789843
ATC codes
L04AG04
UNII
73B0K5S26A
Primary mechanism
Tumor necrosis factor ligand superfamily member 13B inhibitor
Regulatory jurisdictions
mhraemafda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Tumor necrosis factor ligand superfamily member 13B
TNFSF13B · Q9Y275
INHIBITORTumor necrosis factor ligand superfamily member 13B inhibitor

Regulatory timeline

32 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2011-03-09 → 2011-07-13)
Earliest approval
2011-03-09
Latest approval
2025-06-20
Authorities
FDA · EMA · MHRA
Total events
32
fdaU.S. Food and Drug Administration· 30 events
2026-08-21Label change
Label change: BELIMUMAB (BLA761043)
Evidence ↗
2026-08-21Label change
Label change: BELIMUMAB (BLA125370)
Evidence ↗
2025-06-20Indication expansion
Indication expansion: BELIMUMAB (BLA761043)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2011-07-13ApprovalMulti-authority
Approval: Benlysta (EMA)
Indication: Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease… Show full indication

Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti‑dsDNA and low complement) despite standard therapy. Benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis. Benlysta is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti dsDNA and low complement) despite standard therapy.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2019-04-16Safety communicationSafety
Drug Safety Update: Belimumab (Benlysta▼): increased risk of serious psychiatric events seen in clinical trials
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

55 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
55
registered trials across all phases
LATEST COMPLETION 2024
14
Active studies
13
Recruiting
22
Late-stage (III+)
25
Completed
16
Discontinued
PHASE DISTRIBUTIONn = 55
Phase 18Phase 1 / 23Phase 222Phase 2 / 33Phase 310Phase 49

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase 4, Multicenter, Prospective, Open-Label Study Describing the Efficacy and Safety of Belimumab Administered Subcutaneously in Adult Participants With Early Systemic Lupus Erythematosus

RecruitingPH IVGlaxoSmithKlinen=3502029

Pilot Trial of Belimumab in Early Lupus

RecruitingPH IVNorthwell Healthn=302029

Effectiveness of Belimumab After Rituximab in Resistant Primary Juvenile Sjogren's Syndrome

RecruitingPH IVPeking Union Medical College Hospitaln=152026

A Model to Early Predict the Response of Belimumab Treatment in the Patients With Systemic Lupus Erythematosus

Unknown statusPH IVFirst Affiliated Hospital Xi'an Jiaotong Universityn=722026

Sequential Belimumab Followed by T-cell Based Therapy in the Treatment of Systemic Lupus Erythematosus (SUBTLE) - a Preliminary Proof-of-concept Mechanistic Study

Unknown statusPH IVNational University Hospital, Singaporen=802025

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Multi-Centre, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Subcutaneously Administered Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Systemic Lupus Erythematosus (SLE)

CompletedPH IGlaxoSmithKlinen=162024

A Multi-Center, Open-Label Study to Evaluate Safety, Efficacy and Pharmacokinetics of Belimumab Plus Standard Therapy in Chinese Paediatric Patients With Active Systemic Lupus Erythematosus (SLE)

CompletedPH IVGlaxoSmithKlinen=672024

Efficacy and Safety of Belimumab in Neuromyelitis Optica Spectrum Disorders (BEAT NMO)

CompletedPH I/IITianjin Medical University General Hospitaln=142024

A Pilot Study of Belimumab (Benlysta) for Prevention of Chronic Graft-versus-Host Disease Following Allogeneic Hematopoietic Cell Transplantation

CompletedPH IWashington University School of Medicinen=102024

Efficacy and Safety of Belimumab for Prevention of Disease Flares in SLE Patients With Low Disease Activity

CompletedPH IVRenJi Hospitaln=2312022

A Single Arm, 24 Weeks, Pilot Study of Belimumab In Treatment of Early Systemic Lupus Erythematosus

CompletedPH IVPeking Union Medical College Hospitaln=162022
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.